Phase 3
Completed N=628
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03952143 ↗Enrolled (actual)
628
Serious AEs
5.3%
Results posted
Feb 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — -0.63; -0.56 Percentage of HbA1c — p=0.321
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 2 diabetes (T2D).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.63; -0.56 | 0.321 |
| SECONDARY 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) |
100.8; 86.2 | <0.001 sig |
| SECONDARY 2-hour PPG Excursion During MMTT |
133.2; 111.4 | <0.001 sig |
| SECONDARY Rate of Severe Hypoglycemia |
2.00; 0.52 | — |
| SECONDARY Rate of Documented Symptomatic Postmeal Hypoglycemia |
0.13; 0.11; 0.25; 0.34; 0.67; 1.07 | — |
| SECONDARY Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) |
2.49; 2.21 | — |
| SECONDARY Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values |
2.2; 4.4; -12.9; -18.1; -15.9; -21.3 | — |
| SECONDARY Change From Baseline in Insulin Dose |
15.1; 17.8; 0.7; 1.4; 14.7; 16.7 | — |
| SECONDARY Percentage of Participants With HbA1c <7% and ≤6.5% |
44.50; 46.65; 27.23; 27.93 | 0.924 |
Eligibility Criteria
Inclusion Criteria
- Participants must have T2D based on the disease diagnostic criteria World Health Organization (WHO) classification.
- Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily.
- Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs).
- Participants must have a HbA1c ≥7.0% and ≤11.0%.
- Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).
Exclusion Criteria
- Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults.
- Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening.
- Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
- Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
Data sourced from ClinicalTrials.gov (NCT03952143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.